Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Recall
- Recall Number
- Z-1776-2019
- Event Number
- 82722
- Firm
- Conformis, Inc.
- FEI Number
- 3009844603
- Product Code
- LPH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 29, 2019
- Terminated
- April 28, 2020
- Address
- 600 Technology Park Dr, Billerica, MA, 01821-4154
Description
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Conformis issued on 29 Mar 2019 via e-mails to surgeons with upcoming surgeries the following: 1. For surgeons who have already performed the surgeries (i.e. for patients whose implant surgeries were completed between July 31st, 2018 and March 27th, 2019), a letter sent letter advising them of the issue. Confirmation of receipt will be requested. 2. For surgeons who have not performed the surgeries, but have approved the iView surgical plan on or before March 27, 2019, and Conformis has been notified of confirmed surgery dates or Conformis has provided commitment dates on or before May 17th 2019, a. They will be provided with a marked-up iView surgical plan that provides the true dimensions of the manufactured implant and asked to choose to (i) continue with surgery, (ii) postpone surgery to allow Conformis to manufacture a new implant with a head/neck length matching the original approved iView or (iii) cancel the order. b. Should the physician choose to proceed with the surgery using the manufactured implant with the 3 mm discrepancy, it will be shipped to them after receiving their written approval provided that the surgery is scheduled on or before May 17, 2019. c. Should the physician choose to postpone surgery, a new implant will be manufactured to match the approved iView and provided to the surgeon
Nationwide
183